For Patients

Incivek (telaprevir) is a drug of the protease inhibitor class prescribed to treat chronic hepatitis C in adults with stable liver problems, who have not been treated before or who have failed previous treatment. Incivek can cause serious side effects such as birth defects, skin reactions and anemia. Take INCIVEK exactly as your healthcare provider tells you.

Incivek is known to have serious or life-threatening reactions with certain medications such as some cholesterol-lowering medications and some medications prescribed for heart health. Do not take Incivek if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant. You must have a negative pregnancy test before starting treatment, every month during treatment, and for six months after your treatment ends. Tell your doctor if you are breastfeeding. It is not known if Incivek passes into your breast milk. You and your healthcare provider should decide if you will take Incivek or breastfeed. You should not do both.

Our Incivek Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

INCIVEK must be administered with peginterferon alfa and
ribavirin. Refer to their respective prescribing information for their
associated adverse reactions.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

The safety assessment is based on data from pooled
adequate and well-controlled clinical trials including 1797 subjects who
received INCIVEK combination treatment and 493 who received peginterferon alfa
and ribavirin.

Serious adverse drug reactions occurred in 3% of subjects
who received INCIVEK combination treatment compared to none of the subjects
treated with peginterferon alfa and ribavirin. The most frequent serious
adverse events in subjects treated with INCIVEK combination treatment were skin
disorders (rash and/or pruritus) and anemia [see WARNINGS AND PRECAUTIONS].
Fourteen percent of subjects discontinued INCIVEK due to adverse drug
reactions. Rash, anemia, fatigue, pruritus, nausea, and vomiting were the most
frequent adverse drug reactions leading to discontinuation of INCIVEK.

INCIVEK was administered in combination with
peginterferon alfa and ribavirin. The following table lists adverse drug
reactions that occurred in subjects treated with INCIVEK with an incidence at
least 5% greater than in subjects receiving peginterferon alfa and ribavirin
alone (Table 4).

Description of Selected Adverse
Drug Reactions

Anorectal Signs and Symptoms

In the controlled clinical
trials, 29% of subjects treated with INCIVEK combination treatment experienced
anorectal adverse events, compared to 7% of those treated with peginterferon
alfa and ribavirin alone. The majority of these events (e.g., hemorrhoids,
anorectal discomfort, anal pruritus, and rectal burning) were mild to moderate
in severity; less than 1% led to treatment discontinuation and all resolved
during or after completion of INCIVEK dosing.

Laboratory abnormalities

White Blood Cells: Treatment with
peginterferon alfa is associated with decreases in mean values for total white
blood cell, absolute neutrophil, and absolute lymphocyte count. More subjects
treated with INCIVEK had decreases in lymphocyte counts to 499/mm³ or
less (15% compared to 5%). Decreases in total white cell counts to 1,499/mm³ or less were comparable (8% compared to 5%). The incidence of decreases
in absolute neutrophil counts to 749/mm³ or less was 15% in subjects
treated with peginterferon alfa and ribavirin alone compared to 12% among those
treated with INCIVEK combination treatment.

Platelets: Treatment with
peginterferon alfa is associated with decreases in mean platelet counts. More
patients treated with INCIVEK combination treatment had decreases in mean
platelet values of all grades: 47% compared to 36% treated with peginterferon
alfa and ribavirin alone. Three percent of INCIVEK combination treatment
subjects had decreases to 49,999/mm³ or less compared to 1% of those
treated with peginterferon alfa and ribavirin-treated alone.

Bilirubin: Forty one percent of
subjects treated with INCIVEK compared to 28% of peginterferon alfa and
ribavirin-treated subjects had all grade elevations in bilirubin levels; 4% and
2% of subjects, respectively, had greater than or equal to 2.6 x ULN
elevations. Bilirubin levels increased most steeply during the first 1 to 2
weeks of INCIVEK dosing, stabilized and between Weeks 12 and 16 were at
baseline levels.

Uric Acid: During the INCIVEK combination
treatment period, 73% of subjects had elevated uric acid levels compared to 29%
for those treated with peginterferon alfa and ribavirin alone. Shifts to
greater than or equal to 12.1 mg per dL from baseline in uric acid levels were also
more frequent among subjects treated with INCIVEK (7%) compared to
peginterferon alfa and ribavirin (1%). Less than 1% of subjects had clinical
events of gout/gouty arthritis; none were serious and none resulted in
treatment discontinuation.

Additional Data from Clinical Trials

In the analysis of an additional study (Trial C211), the
safety profile of combination treatment with INCIVEK 1125 mg twice daily was
similar to the safety profile for patients receiving combination treatment with
INCIVEK 750 mg every 8 hours (q8h) [see Clinical Studies]. No new safety
findings were identified.

Post-marketing Experience

The following adverse reactions have been identified
during post-approval use of INCIVEK. Because these reactions are reported voluntarily
from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.